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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K141390
Device Name INTERMITTENT PNEUMATIC COMPRESSION DEVICE
Applicant
Wuhan Landing Medical Hi-Tech, Ltd.
818 Gaoxin Rd. E. Lake High Tech Development Zone
Floors 1&2,Units B&C&D Bldg. #B7 Med Equipment Pk
Wuham,  CN 430206
Applicant Contact YAN LIU
Correspondent
Wuhan Landing Medical Hi-Tech, Ltd.
818 Gaoxin Rd. E. Lake High Tech Development Zone
Floors 1&2,Units B&C&D Bldg. #B7 Med Equipment Pk
Wuham,  CN 430206
Correspondent Contact YAN LIU
Regulation Number870.5800
Classification Product Code
JOW  
Date Received05/27/2014
Decision Date 11/18/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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